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The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis

NCT00904254 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-02-03

No results posted yet for this study

Summary

The primary objective of this study is to proof the concept of EP 1645 as a diagnostic tool for carotid artery atherosclerosis and plaque instability and to assess the safety and tolerability of this diagnostic agent, a monoclonal antibody fragment (Fab') conjugated with the diagnostic radionuclide 99mTc. Safety and tolerability will be determined by adverse events (AEs) observed and reported upon administration of the product and the absorbed dose of radiation.

Conditions

  • Carotid Stenosis

Interventions

RADIATION

EP 1645/Solution For Injection, 99mTC

(Fab-fragment of Anti-human CD4,technetium-99m)

Sponsors & Collaborators

  • Klinikum Chemnitz gGmbH

    collaborator OTHER

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Christoph Schindler Schindler, MD · Institute of Clinical Pharmacology, Medical Faculty, Technical University Dresden

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904254 on ClinicalTrials.gov